Tag: NSCLC

Sigvotatug Vedotin in Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer: Topline Results from the Phase 3 SigVie-002 Study

Izalontamab Brengitecan Receives U.S. FDA Breakthrough Therapy Designation Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Data from the dose escalation portion of the Phase 1/2 study of JK06 in patients with unresectable locally advanced or metastatic cancer, including non-small cell lung cancer (NSCLC) and breast cancer, is being presented at the European Society for Medical Oncology (ESMO) Congress, being held October 17 - 21, 2025, in Berlin, Germany.[1]

ESMO 2025: First Global Phase I Results of Izalontamab Brengitecan in Patients with Advanced Solid Tumors

Daiichi Sankyo and Merck & CO/MSD have voluntarily withdrawn the Biologics License Application (BLA) seeking accelerated approval in the U.S. for patritumab deruxtecan (HER3-DXd) in patients with previously treated locally advanced or metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) previously treated with two or more systemic therapies.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

A first patient has been dosed in the TROPION-Lung12 phase 3 trial (NCT06564844), a global, multicenter, three-arm, open-label phase 3 trial designed to evaluate the efficacy and safety of adjuvant datopotamab deruxtecan (6 mg/kg; Datroway®; Daiichi Sankyo and AstraZeneca; see: ADC Drug Map) in combination with the PD-1/TIGIT bi-specific antibody rilvegostomig* (750 mg) or rilvegostomig monotherapy (750 mg) monotherapy versus observation or standard of care adjuvant chemotherapy regimens.

AbbVie has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V/ABBV-399; See Drugmap) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.

During the upcoming annual meeting of the European Society for Medical Oncology (ESMO), being held in Barcelona, September 13-17, 2024, expect presentations to include new data on advances in the treatment of hard-to-treat cancers using approved and investigational agents, including enfortumab vedotin (Padcev™; Astellas/Pfizer/Seagen), Zolbetuximab (previously known as IMAB362), Enzalutamide (Xtandi®; Astellas/Pfizer) and various pipeline products.

Preclinical data highlighting the differentiating properties of Mythic Therapeutics' investigational cMET-targeting antibody-drug conjugates (ADC), MYTX-011, published in April 30, 2024 edition of Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR), demonstrated that this novel ADC which leverages Mythic’s innovative FateControl™ technology, actively navigated inside of cells, potentially increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells.